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NCT03229798 · ClinicalTrials.gov registry record · Phase 1
Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)
A Phase 1 study of Migraine Disorders, sponsored by Sorrento Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03229798: Completed Phase 1 study of Migraine Disorders, sponsored by Sorrento Therapeutics.
NCT03229798 is a Phase 1 study of Migraine Disorders that has completed, run by Sorrento Therapeutics. The registered enrollment target is 19 participants, below the 314-participant average among 21 other Migraine Disorders trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03229798, a Phase 1 study of Migraine Disorders, has completed, sponsored by Sorrento Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™ system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.
Primary Outcome
Pharmacokinetic profile with Cmax (maximum concentration) of drug in blood, ng/mL
Conditions Studied
Interventions
- DRUG Sumatriptan Succinate Oral Tablet
- COMBINATION_PRODUCT Transdermal delivery of sumatriptan succinate
Study Locations (1)
North Carolina
- Carolina Phase 1 Research - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2018-03-28 |
| Phase | Phase 1 |
What the finished NCT03229798 record still lists
NCT03229798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 314-participant average among 21 other Migraine Disorders trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Migraine Disorders appearing as the primary indexed condition, and to 2 interventions - of which Sumatriptan Succinate Oral Tablet is the first listed.
NCT03229798 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03229798 about?
NCT03229798 is a clinical study titled "Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)". Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™ system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.
What is the current status of trial NCT03229798?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-01-17. Estimated completion is 2018-03-28.
What conditions does trial NCT03229798 study?
This clinical trial studies the following conditions: Migraine Disorders.
What interventions are being tested in trial NCT03229798?
The interventions under investigation include: Sumatriptan Succinate Oral Tablet (DRUG), Transdermal delivery of sumatriptan succinate (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03229798?
This trial is sponsored by Sorrento Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03229798 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03229798's enrollment target sits among peer trials
19 20th of 21 higher than 2 of 21 other Migraine Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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